Although the initiative was well received, access groups pointed out the fact that Africa is still dependent on Europe for the drug substance. | Robert Atanasovski/AFP via Getty ImagesClick play to hear this article from Amazon PollyAfrica is poised for a bold move to turn its fortunes in coronavirus vaccination manufacturing, taking it from dependence on imports to self-sufficient production life-saving jabs against coronavirus, TB, and perhaps even HIV.Two companies are creating an mRNA technology-transfer center at the tip continent, which could allow it to produce its own vaccines on its terms. This is a way to show how vulnerable countries are, if they don't have the necessary vaccine manufacturing capabilities. Africa imports around 99 percent of routine vaccines and is the least protected against coronavirus.In October 2020, South Africa and India proposed an intellectual property waiver to the World Trade Organization as a countermeasure to this shortage of vaccines. This would allow countries with lower incomes to produce coronavirus vaccines, without worrying about infringing patents.The EU has been the main blocker to the proposal, causing it to remain deadlocked. Even if the proposal was accepted, it would not address the important issue of how to produce vaccines.Another idea was born: The World Health Organization proposed an mRNA technology-transfer hub, which would allow multiple companies to share knowledge about how to make vaccines. Even the French President Emmanuel Macron endorsed it.Afrigen Biologics, Vaccines, and Biovac have been selected as the partners in the initial hub. Afrigen will be the trainer in chief, and transfer technology for the mRNA vaccinations to other locations, including Biovac.It was not an accident that mRNA technology was chosen.No mRNA-based vaccine or treatment had been approved before the pandemic. The EU was convinced by the success of Moderna and BioNTech/Pfizer vaccines to switch to mRNA as a source of future supplies.Its potential applications include cancer, Ebola and HIV. Pharmaceutical companies are keen to hold on to this newly developed technology, but it is precisely this potential that drives them to be even more committed.Herein lies the problem: Big Pharmas support is required to get the hub operational in a year that could still end the pandemic. Big Pharma isn't interested: Pfizer and Moderna have not expressed an interest in the facility.POLITICO also received no comment from the drugmakers regarding their possible involvement.Jaume Vidal (senior policy advisor for European projects at Health Action International) warned that Pharma is engaging in a very dangerous game. His belief is that the actions of Pharma are in fact condemning thousands.From theory to practiceThe WHO hopes to create a hub that brings together companies that have the knowledge to make mRNA vaccines. Ideally, a drugmaker with a previously approved vaccine with manufacturers who can be trained to make the vaccine. Afrigen would play a role in this case, helping to transfer technology from an mRNA vaccination developer to other manufacturers with the support and assistance of a network universities and the Africa Centres for Disease Control and Prevention.This is not the first time that the WHO has done it. Similar technology transfer programs for influenza vaccines have resulted in hundreds of millions more flu jabs over the years.The WHO stipulates that the hub may use the technology in one of two ways. It can either be free from intellectual property restrictions in low- or middle-income countries or make these rights available to recipients by granting non-exclusive licenses to export, produce and distribute COVID-19 in these countries.Marie-Paule Kieny is director of research at Inserm, and chair of U.N.-backed Medicines Patent Pool. A hub partner, she argues that it won't run roughshod over existing licensing arrangements.Kieny pointed out other partnerships made by the Medicines Patent Pool, which includes signing agreements for HIV antiretrovirals patent holders. He said that it is aware of Pharma's concerns regarding competition and that licenses are usually limited to a specific territory. For example, an mRNA vaccine made in South Africa would not be sold or imported to the U.K.Petro Terblanche is the managing director of Afrigen. He also believes that terms should be determined on a case-by-case basis. This will happen in accordance.South Africa was chosen deliberately. Kieny stated that the due diligence conducted by both the Medicines Patent Pool (WHO) and the Medicines Patent Pool indicates that South Africa has no IP barriers for the production mRNA vaccines. She added that this means there is no current patent application in South Africa for an mRNA vaccination, although a patent application may still be filed.This distinction is crucial: The hub and waiver could be used together, but it's not dependent on them. The waiver, if implemented, would allow production to continue. However, a waiver would only be effective for the pandemic and not override the eventual requirement for compulsory or voluntary licensing.Losing controlThere's more to the story than just legal fine print. Big Pharma doesn't believe that companies will accept the terms of the hub.Thomas Cueni is the director general of IFPMA's international pharma lobby. He said that the industry supports the goal of equal access to global pharma markets, but it needs to be open-minded about accepting that companies may not be looking for total sellout and instead engage in technology transfer and voluntary licensing.He explained that drugmakers must have high levels of trust in the fact that the recipient of the technology transfer, licensing, has skilled workers, and can be trusted to adhere to the agreements.He also said that the WHO could have done a better work, adding that he was only informed about the hub by a press release.Alain Alsalhani is a pharmacist who has worked for Doctors Without Borders since 2009. He says that the fundamental fact of Big Pharma's refusal to do anything without direct benefits is a constant truth. He said that drugmakers can share their technology with African manufacturers as a form social responsibility or to improve their public image bilaterally.He said that they get all the positive press, but they also have complete control over everything. "What they see in [their] hub is clearly an opportunity for them to lose control of [their] technology."These comments were made to POLITICO by him in July. His prediction was realized just two weeks later. BioNTech and Pfizer announced bilateral plans to expand in Africa on July 21st. Biovac will complete the last stage of production, filling and finishing the BioNTech/Pfizer vaccine by 2022.Although the initiative was applauded, access groups pointed out the fact that Africa is still dependent on Europe to fill and finish the drug substance.Future proofEven hub advocates admit that they must play the long game. The pace of tech transfer is slow and neither Afrigen or Biovac have experience with mRNA technology. If the technology is already in use, it will take at least a year to produce the first vaccines. It may take 18 months if the hub uses a mRNA vaccine that is still being developed.It is worth the effort if these jabs only start to trickle in mid-2022.Kieny believes it is. He points out that booster doses and periodic vaccination may be required by mRNA coronavirus vaccines.Terblanche says that it's more than just this pandemic. The ambition to choose mRNA for the platform is not to pursue a next-generation technology.Big Pharma is welcome to join the hub, but they can be removed if necessary. The platform must survive after a pandemic. She stated that it must be multi-purpose and offer multiple products. This meant that Ebola, TB, HIV, and flu would all be covered.It will take time, she stated.Terblanche spoke with POLITICO just before BioNTech announced Monday that it will work with the hub for future iterations of its mRNA-malaria vaccine. BioNTech will evaluate multiple vaccine candidates and select the most promising. The first candidate will be eligible for clinical trials by the end of 2022, it is hoped.Vidal and other activists are excited about the potential of the hub. It could lead to African manufacturers of mRNA vaccinations against TB or malaria in the future. He said that it is crucial for this hub to succeed.Kieny said that despite all the hype surrounding mRNA vaccines the technology is very simple to use. It can be used by all manufacturers of drugs. This is a crucial point, even if you have some experience in biologicals. It is also easier to scale up production with the technology, as Pfizer's impressive ramp-up in Europe this spring demonstrated.Are you playing politics?Not only is the hub being hounded about whether a pharma firm will join, but also whether it has enough expertise to succeed. IFPMAs Cueni is one example of doubts about the WHO's ability to manage it.He believes that the Medicines Patent Pool has succeeded in building trust around licensing agreements. However, the WHO still has a lot of work to do.He said that they are playing too much politics, and that their operational record in the field is not very impressive.Cueni was also critical of the WHO's creation of the hub. He said that the WHO did not consult the WHO before creating it.What strategy are they using? Do they hope companies will take notice? They will be the heros because they announced it. He asked if they could make us villains if it failed.Cueni's claims were not addressed by a spokesperson for WHO. He did however note that the WHO will continue to encourage all pharmaceutical organizations to work harder to end inequity. This includes sharing technology, know-how and licenses and temporarily waiving intellectual property.HAIs Vidal agrees with Cueni in that the work of C-TAP and the hub overlap but can also contradict one another. He said that this is something to avoid at all cost.The hub's participants argue that C-TAP was primarily concerned with patents. However, the hub is all about sharing technology and training others how to use it.Terblanche is not afraid of the enormous challenge ahead, and Terblanche has no doubts that two small South African businesses have the skills. "I think it's fair to critics to ask 'wow! so how are these guys going do it?'," she said. She said.Terblanche said that we don't underestimate this challenge and that the ambition is huge.She says South Africans underestimate the knowledge base. There are more than 60 academic degrees among her 15-strong team.She laughed and said that they are running at high energy right now. But not before the hub is complete.Update: This article was updated to reflect the announcement by BioNTechs of plans for an mRNA-based malaria vaccine.This article is part POLITICO's premium policy service, Pro Health Care. Our specialized journalists will keep you up to date on the latest topics in health care policy, including drug pricing, EMA and vaccines. For a free trial, email [email protected]
